FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Jun 17 2010

Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).  The Company had announced on June 1, 2010 that the FDA accepted the Contrave NDA filing for review.  The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.  

"It's an exciting year for Orexigen as we move through the review process of the Contrave NDA," said Michael Narachi, President and CEO of Orexigen.  "We believe that if approved, Contrave will become an important therapeutic option for obese patients, making weight loss and weight maintenance an achievable cornerstone in the treatment of obesity and its common co-morbidities."